Bronchoscopy Study for Severe Asthma

NCT ID: NCT01745809

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this research study is to collect lung tissue and fluid from two groups of people: those who have severe asthma, and those who do not. These samples will then be tested in a laboratory to identify differences in the lung tissue cells and fluids that may exist between these two groups of people.

Conditions

Severe Persistent Asthma

Study Groups

Severe Asthmatics

Subjects with a pre-existing physician diagnosis of asthma with reversible airflow obstruction of at least 12%.

Bronchoscopy

Intervention Type: PROCEDURE

Subjects will have a screening visit and, if they qualify to take part in the study, they will undergo a single bronchoscopy procedure. During the bronchoscopy, bronchoalveolar lavage (BAL) and bronchial brushings will be performed on each subject.

Healthy non-smokers

Subjects will be never smokers or former smokers for the past year and less than 10 pack years lifetime with no history of asthma or any other lung disease.

Bronchoscopy

Intervention Type: PROCEDURE

Subjects will have a screening visit and, if they qualify to take part in the study, they will undergo a single bronchoscopy procedure. During the bronchoscopy, bronchoalveolar lavage (BAL) and bronchial brushings will be performed on each subject.

Interventions

Bronchoscopy

Subjects will have a screening visit and, if they qualify to take part in the study, they will undergo a single bronchoscopy procedure. During the bronchoscopy, bronchoalveolar lavage (BAL) and bronchial brushings will be performed on each subject.

Intervention Type: PROCEDURE

Other Intervention Names

Fiberoptic Bronchoscopy; Bronchoalveolar Lavage

Eligibility Criteria

Inclusion Criteria

1. Subject is an adult male or female between 18 and 65 years of age inclusive.

2. Subject must have a pre-history of a physician's diagnosis of severe asthma (according to GINA classification) with some reversible airway obstruction (shown by peak flow or FEV1 in the last 12 months with a change of 12% in the absolute FEV1 measurement) and an exclusion of other significant pulmonary diseases (i.e., cystic fibrosis, tuberculosis, Interstitial Lung Disease and bronchopulmonary dysplasia)

3. Subject has a positive methacholine test (PC20 < 16). This test sometimes cannot be performed in severe asthmatics because of low baseline FEV1 (< FEV1 50%). SABA reversibility of FEV1 is sufficient to define asthma in absence of MCh PC20.

4. Subject's asthma has been stable for the past 30 days.

5. The subject has been a non-smoker for the past year and should have less than a 10 pack year history.

6. The subject must be capable of and willing to provide written informed consent

7. The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.

1. Subject is an adult male or female between 18 and 65 years of age inclusive. (Subjects will be age and gender matched) With age matching, we will enroll in a manner that age and gender will be matched 1:1 in the following cohorts: age 21-30, 31-40, 41-50, 51-60, 61-65.

2. Subject must have an exclusion of asthma or other significant pulmonary diseases (i.e., cystic fibrosis, tuberculosis, Interstitial Lung Disease and bronchopulmonary dysplasia)

3. The subject has been a non-smoker for the past year and should have less than a 10 pack year history.

4. The subject has a negative methacholine test (PC20 > 16) and does not use inhaled steroids and/or SABA.

5. The subject must be capable of and willing to provide written informed consent

6. The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.

-

Exclusion Criteria

<!-- -->

1. As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.

2. The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer), prior to the current study.

3. No oral steroids within the last 3 months.

4. No current anticoagulant and/or antiplatelet therapy.

5. The subject has a history of alcohol or drug abuse within the last 5 years.

6. The subject has history of hepatitis B, hepatitis C, or HIV virus.

7. The subject has a history of chemotherapy or radiotherapy within the last 2 years.

8. The subject has a history of diabetes.

9. The subject is pregnant or lactating.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reynold Panettieri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Airways Biology Initiative at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

814383

Identifier Type: -

Identifier Source: org_study_id